Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03606785

Enrollment

Registered

2018-07-31

Start date

2018-08-05

Completion date

2020-01-31

Last updated

2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

Keywords

colorectal,blood, transfusion,haemorrhage,tranexamic acid.

Brief summary

A total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking surgery for colorectal cancer will be randomized into two equal groups one will receive tranexamic acid and one placebo. The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.

Interventions

DRUGTranexamic Acid Injection

The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision

DRUGplacebo injection

patients will receive a placebo of 100 mL 0.9% normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery. * Age above 18 years & less than 65 years.

Exclusion criteria

* Thrombophilia or any bleeding disorder. * Previous or active thromboembolic disease. * Family history of thromboembolism. * Known Allergy to TA. * Liver dysfunction. * Preexisting renal dysfunction (serum creatinine \>1.2 mg/dL). * Coronary stent insertion within a year prior to operation. * Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure), * Lifelong warfarin therapy for thromboembolism prophylaxis.

Design outcomes

Primary

Measure	Time frame	Description
reduction in blood loss	1 month	Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).The amount of drained blood will be measured in 1st 24 hours.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026